The OVAL Study: A Randomized, Controlled, Double-Arm,Double-Blind, Multi-Center Study of Ofranergene Obadenovec (VB-111) Combined with Paclitaxel vs. Paclitaxel Combined with Placebo for the Treatment of Recurrent Platinum-Resistant Ovarian Cancer

Study on Investigational Medication with Chemotherapy for Ovarian Cancer

Recruiting
18 years - 100 years
Female
1 Location

Brief description of study.

The purpose of this study is to compare the efficacy and safety of the experimental drug VB-111 in combination with the standard chemotherapy drug paclitaxel compared to using paclitaxel combined with placebo.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ovarian Cancer
  • Age: 18 years - 100 years
  • Gender: Female

Inclusion Criteria

In order to be eligible to take part in this trial, patients must meet the following criteria:

  • Histologically confirmed epithelial ovarian cancer and documented disease.
  • Patients must have platinum-resistant disease.

For a full list of participation criteria, please visit clinicaltrials.gov.

Updated on 19 Feb 2024. Study ID: 1901313859 (VB-111-701/GOG-3018)

This study investigates the effects of an investigational medication combined with a standard chemotherapy drug called paclitaxel in patients with ovarian cancer. Ovarian cancer is a disease where cancer cells form in the tissues of the ovary. The study aims to compare the investigational medication and paclitaxel with a combination of paclitaxel and a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medication.

Participants in the study will receive either the investigational medication with paclitaxel or paclitaxel with a placebo. The study will monitor the safety and effectiveness of these treatments in managing ovarian cancer, focusing on patients whose disease does not respond to platinum-based chemotherapy.

  • Who can participate: Participants must have epithelial ovarian cancer confirmed by histology and have platinum-resistant disease.
  • Study details: Participants will receive treatment with either the investigational medication and paclitaxel or paclitaxel with a placebo.

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